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Clinical Performance BioHermes

Serum samples from a cohort of 172 patients were tested using our test. The combined
cohort consisted of healthy people (N=40) and volunteers who have been immunized by
SARS-CoV-2 Neutralizing
injecting two doses of vaccine against SARS-CoV-2 (N=132). Serum samples of vaccine Antibodies Test Kit
group were collected at 7 - 28 days after the volunteers vaccinated with the second dose
of vaccine. Neutralizing antibodies of all serum samples from 172 patients were tested by Experience the novel and ideal test solution in the COVID-19 testing market
virus neutralizing assay.
BioHermes SARS-CoV-2 Neutralizing Antibodies Test Kit is a novel COVID-19 serological
test kit used for detecting neutralizing antibodies that are the most promising predictor of
immunity condition of COVID-19.
Virus Neutralizing Assay

Healthy people Vaccine Group Combined cohort


Method (N=132)
(N=40) (N=172)

Negative Positive Negative Positive Negative Positive


BioHermes Negative 40 0 18 0 58 0
SARS-CoV-2 Positive 0 0 1 113 1 113
Neutralizing
Antibodies Sensitivity 100% 100%
Test Kit Specificity 100% 94.74% 98.31%

Specificity 98.31% and Sensitivity 100%

Product Information

Storage Easy to get started High efficiency


Product Name Sample Type Packing Size Shelf Life Qualification
Condition Traditional 96 wells ELISA methodology, Get the results less than 1 hour, much
no special training for the Lab professio- more efficient and safe than the
SARS-CoV-2 96 Tests nals; compatible with traditional ELISA traditional virology methodology testing
2-8 ℃
Neutralizing Serum/
192 Tests 6 months
Antibodies Plasma
480 Tests automation equipment
Test Kit

Sample type High Clinical Performance


Can be used with serum and plasma Species & isotype independent, with
samples specificity 98.31% and sensitivity 100%
Wuxi BioHermes Bio & Medical Technology Co., Ltd. Tel: + (86) 510-85385897 Ext: 2071 comparing to Virus Neutralizing Assay
No.136 Mashan Meiliang Road, Binhu, Wuxi, Jiangsu E-mail: info@biohermes.com.cn www.biohermes.com (VNT, gold standard)
214092, China
What you need to know about Neutralizing Antibodies Test Application
SARS-CoV-2 Neutralizing Antibodies (NAb) Neutralizing Antibodies Product/Vaccine Research & Development
Facilitate the development of neutralizing antibodies product and monoclonal antibody
therapy development.

Vaccination Evaluation
Evaluation of vaccine efficacy & monitor titers after vaccination.

Clinical Treatment Value


Determine who may qualify to donate blood that can be used to manufacture convalescent
plasma as a possible treatment for those who are seriously ill from COVID-19.

Epidemiology Research
Determining the longevity of potential immunity to of COVID-19 both in individuals and the
broader population. Immune surveillance of large populations or regions.

The spike protein (S) of COVID-19 contains a virus binding domain. The virus binding domain Mechanism Study
of the SARS-CoV-2 S protein strongly interacts with the human cell surface receptor ACE2 SARS-CoV-2 Spike protein (S) /ACE2 receptor interaction studies.
receptor leading to endocytosis into the host cells of the deep lung and viral replication.

SARS-CoV-2 neutralizing antibodies are part of the humoral response of the adaptive immune
system against viruses. By binding specifically to virus binding domain on the SARS-CoV-2
virus, neutralizing antibodies prevent the virus particle from interacting with host cells’ ACE2 Neutralizing Antibody ELISA Test Advantages
and protect the host cell from being infected.
Neutralizing Antibody ELISA Test OVER Conventional Neutralizing Antibody
Test (VNT)
Principle of SARS-CoV-2 Neutralizing
Antibodies Test Kit BioHermes Neutralization Antibody Virus Neutralization Assay (VNT)
The test kit is a blocking enzyme linked immunosorbent assay (ELISA) detection tool, which ELISA test
mimics the virus neutralization process. The kit contains two key components: HRP
conjugated recombinant SARS-CoV-2 virus binding domain fragment (HRP-AG) and the
human ACE2 receptor protein (hACE2). The protein-protein interaction between HRP-AG
and hACE2 can be blocked by neutralizing antibodies against SARS-CoV-2 virus binding Flexible & Safe: working in general Strict condition: Require facilities
domain. Lab settings and no BSL3 condition with bio-safety level 3 (BSL3)
HRP labeled
virus binding
required
ACE2 receptor Binding antibody
domain The virus binding domain still bind to the
hACE2 receptor on the plate and
NAb
generates strong signals, indicating no
Fast: Less than 1 hour to perform Time-consuming: takes days to perform
Negative neutralizing antibody present in the
sample Convenient: can be automation & Requires high level expertise to read
high-throughput, easy to interpret
Neutralizing antibody
Neutralizing antibody present in the
NAb sample, which binds to the HRP-AG and Cost-effective with ELISA test Highly cost
prevent them binding to hACE 2 receptor
Positive on the plate. HRP-AG is removed after
washing step and no signal detected.

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